Approval for OPEN

Governance Activity Reviews
#1

The OPEN project is a EU H2020 funded research project that investigates DIY Artificial Pancreas Systems (DIYAPS).
Our study has four main aims 1) to examine the clinical and 2) quality of life outcomes of users before and after starting on a DIYAPS, 3) to identify potential technical improvements that could be made to artificial pancreas technology of all kinds, and 4) to investigate how more people can benefit from the innovations being developed by the DIY community.

The OPEN project on Open Humans will enable a simplified way for the participants of the study to share their retrospective device data sets with the OPEN research group.

As part of the OPEN survey where participants will answer questions in a survey about their quality of life and their diabetes and others, they will also be asked to join Open Humans and the OPEN project to donate their device data. This will allow us - with users explicit consent (optional) - to link the survey answers with their device data. Everything will be explained in depth as part of the information sheets for the study, and has been approved by the IRB overseeing the OPEN project.

The OPEN project will ask for permission for Nightscout Data Transfer, Nightscout Data Transfer (Automated), AndroidAPS Uploader and Data Selfies. The project will follow GDPR guidelines.

Furthermore, in order to make participating as straightforward as possible, we have developed a system called “Gateway” (see attached screenshots) that guides the user through the process of filling out the survey and joining the OPEN project on Open Humans. For simplicity, linking the REDCap survey dataset with the Open Humans Project Member ID is done automatically in the background.

The study has undergone ethical review at University College Dublin and has received approval by their IRB.

This project has received funding from the European Commission’s Horizon 2020 Research and Innovation Programme under the Marie Sklodowska-Curie Action Research and Innovation Staff Exchange (RISE) grant agreement number 823902.

Should this project be visible and available for all Open Humans members to join?
Please vote Approve or Deny, and/or comment.
Quick links

  • Activity page: https://www.openhumans.org/activity/open/
  • Project review guide: Activity Review Guide
  • Project guidelines: https://www.openhumans.org/community-guidelines/#project
    Project info
  • Title: OPEN
  • Managed by: Shane O’Donnell (University College Dublin)
  • Description: The “OPEN” project brings together an international and intersectoral consortium of patient innovators, clinicians, social scientists, computer scientists and patient advocacy organizations in order to investigate various aspects of Do-it-Yourself Artificial Pancreas Systems (DIY APS) that are used by an increasing number of people with diabetes.
  • Project website: https://open-diabetes.eu
  • Connections: 2 members
  • Data received: Diabetes data (e.g. CGM, insulin pump etc.)

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#2

This looks clear to me! I would vote for approve.

It seems to me that the following questions are all “yes”,

  • Is this activity following Activity Guidelines?
  • Is this activity communicating clearly about…
    • who manages it?
    • what members will be asked to do?
    • what is in the data it has access to?
    • security, privacy, and data management?
  • Are the claims made by this activity realistic? Are its communications misleading or untruthful?
  • Would a member’s decision to join be sufficiently informed?

Plus this activity is a research study with ethics board (IRB) oversight and approval. :+1: In these cases I don’t think we need as high a level of input from community to decide it’s OK, but I’d like to leave this open for a bit longer in case anyone else has feedback. :slight_smile:

@TebbeUbben are you able to upload a copy of the study’s IRB approval letter? We request a copy of this this for an activity to be listed as a “study”.

Minor feedback: I wonder if the activity description in Open Humans could be edited slightly to make it clear that this activity is only seeking / relevant to members if they’re DIYAPS users. (I think someone would eventually work that out, but maybe saying it first thing helps avoid someone getting confused!)

#3

As a follow-up here: I’ve privately received a copy of the approval letter, so that item is good to go. :+1:

#4

I have adjusted our description to better reflect whom we are looking for. I want to clarify that we are not just interested in DIYAPS users, but also in their relatives and people who failed to build these systems.

1 Like
#5

Thanks, I’ve looked over it as well and it looks good to me too, approve! :+1:

#6

I’ve marked this project as “approved” on the site! Thanks all.

I’ll leave this thread open for now in case there’s further feedback etc, and will close it if there’s no further discussion. :+1: